Pro-Step LH Ovulation Prediction Test
FDA 510(k) K943252 · Disease Detection International, Inc.
510(k) numberK943252
Submission
- Device name
- Pro-Step LH Ovulation Prediction Test
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- July 6, 1994
- Decision date
- October 25, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013582 | Maybe?Mom Mini Ovulation MicroscopeCEP · Traditional | Maybe?Mom | 01/16/2003SE |
| K022829 | Instant-View LH Ovulation Predicting TestCEP · Abbreviated | Alfa Scientific Designs, Inc. | 11/05/2002SE |
| K021409 | At Home Ovulation Test, Model 9032CEP · Special | Phamatech, Inc. | 05/24/2002SE |
| K013874 | Clearplane Easy Ovulation TestCEP · Traditional | Unipath , Ltd. | 02/19/2002SE |
| K013323 | TCI-31 Lifelong Ovulation TesterCEP · Traditional | Tci New York | 12/05/2001SE |
| K012252 | Quik-Check Ovulation PredictorCEP · Traditional | ACON Laboratories, Inc. | 08/24/2001SE |
| K010244 | Sure Check Ovulation PredictorCEP · Traditional | Chembio Diagnostic Systems, Inc. | 05/02/2001SE |
| K002867 | Inverness Medical Ovulation Predictor TestCEP · Special | Selfcare, Inc. | 10/12/2000SE |
| K991466 | Early Ovulation Predictor (Cassette), One Step Ovulation Predictor (Cassette), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
| K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…CEP · Traditional | Selfcare, Inc. | 05/25/1999SE |
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| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
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Questions and answers
When was Pro-Step LH Ovulation Prediction Test cleared by the FDA?
Pro-Step LH Ovulation Prediction Test (K943252) received a 510(k) decision of Substantially Equivalent on October 25, 1994, 111 days after the submission was received.
What is the product code of K943252?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.